
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50013-50014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0903]


Providing Submissions in Electronic Format--Postmarketing Safety 
Reports for Vaccines; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Providing Submissions in 
Electronic Format--Postmarketing Safety Reports for Vaccines; Guidance 
for Industry.'' The guidance document provides information and 
recommendations pertaining to the electronic submission of 
postmarketing safety reports involving vaccine products marketed for 
human use with approved biologics license applications (BLAs), 
including individual case safety reports (ICSRs) and attachments to 
ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting 
System (VAERS). VAERS is a national vaccine safety surveillance program 
that is co-sponsored by the Centers for Disease Control and Prevention 
(CDC) and FDA. FDA published in the Federal Register a final rule 
requiring that certain postmarketing safety reports for human drug and 
biological products, including vaccines, be submitted to FDA in an 
electronic format that the Agency can process, review, and archive. The 
guidance is intended to help applicants required to submit 
postmarketing safety reports involving vaccine products to comply with 
the final rule. The guidance announced in this notice finalizes the 
draft guidance of the same title, dated July 2014, and supersedes the 
document entitled ``Guidance for Industry: How to Complete the Vaccine 
Adverse Event Report System Form (VAERS-1)'' dated September 1998.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

[[Page 50014]]


ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled 
``Providing Submissions in Electronic Format--Postmarketing Safety 
Reports for Vaccines; Guidance for Industry.'' The guidance document 
provides information and recommendations pertaining to the electronic 
submission of postmarketing safety reports involving vaccine products 
marketed for human use with approved BLAs, including ICSRs and ICSR 
attachments, into VAERS. VAERS is a national vaccine safety 
surveillance program established in response to the National Childhood 
Vaccine Injury Act of 1986, which requires health professionals and 
vaccine manufacturers to report specific adverse events that occur 
after the administration of routinely recommended vaccines. VAERS is 
co-sponsored by CDC and FDA. The guidance is applicable to vaccine 
products marketed for human use with approved BLAs for which CBER has 
regulatory responsibility. The guidance does not apply to any other 
biological product. Postmarketing ICSRs and ICSR attachments for 
biological products, which are not addressed by the guidance, are 
processed into the FDA Adverse Event Reporting System database.
    In the Federal Register of June 10, 2014 (79 FR 33072), FDA 
published a final rule requiring that certain postmarketing safety 
reports for human drug and biological products, including vaccines, be 
submitted to FDA in an electronic format that the Agency can process, 
review, and archive. The guidance is intended to help those applicants 
required to submit postmarketing safety reports involving vaccine 
products to comply with the final rule.
    In the Federal Register of July 18, 2014 (79 FR 42022), FDA 
announced the availability of the draft guidance of the same title 
dated July 2014. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. The 
guidance includes changes to clarify the reporting requirements and 
technical process for submitting reports to VAERS. In addition, 
editorial changes were made to improve clarity. The guidance announced 
in this notice finalizes the draft guidance dated July 2014 and 
supersedes the document entitled ``Guidance for Industry: How to 
Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated 
September 1998.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Providing Submissions in Electronic Format--
Postmarketing Safety Reports for Vaccines. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 310 and part 314 have been 
approved under OMB control number 0910-0230. The collections of 
information in 21 CFR 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), and 
600.80(h)(2) (Form FDA 3500A), have been approved under OMB control 
number 0910-0770. The collection of information in 21 CFR part 600 is 
approved under OMB control number 0910-0308. The collection of 
information in Form FDA 3500A is approved under OMB control number 
0910-0291.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20312 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P


